Nanomaterials: Industrial Policy and Legislation Otto Linher DG Enterprise and Industry EESC, 9 September 2015 European Commission

„Nanomaterial“means a […] material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm nm  Nanomaterials are not necessarily new and innovative  Not all innovative nanotechnology contains nanomaterials. Nanomaterials – Myths and Reality

Nanomaterial properties are not as unknown as often reported 20 years of focused research is not without results Nanomaterials are similar to normal chemicals/substances in that some may be toxic and some may not: the dosis is decisive Nanomaterials – Myths and Reality

Global market (excluding pigments) annually around 11 million tonnes (market value around 20 bn €)  French nanomaterial registry: around tonnes for France Global market value of products containing nanomaterials around 2 trillion € Direct number of jobs in the EU in the area of nanotechnology around to Nanomaterials on the Market

Market for Selected Nanomaterials NanomaterialSecond Regulatory Review (global, t/a) Nano registry France (t/a) Carbon black Synthetic amorphous silica Aluminium oxide Yellow pigment/iron oxide…540 Titanium dioxide Cerium oxide Zink oxide Carbon nanotubes and nanofibresSeveral hundreds to thousands unclear Nanosilver200,0001-0,001

 Food additives (Anticoagulants)  Fillers (e.g. paper, plastics, tyres)  UV-filters in sun creams  Antibacterial applications  Paints, varnishes, adhesives  Catalysts  Batteries, solar cells  Medicine, medical devices, tumour therapies  Nanoelectronics (mostly nanostructured materials, and not nanomaterials) Examples of Applications of Nanomaterials and Nanotechnology

Nanotechnology is one of 6 Key Enabling Technologies for innovation Example for high-tech material: Graphene  integrated circuits, transistors, transparent conductive electrodes  solar cells, energy storage, gas sensors  medicine  ethanol destillation Nanoelectronics Role of Nanomaterials/Nanotechnology in Industrial Policy

Legislation on Nanomaterials: Overview Horizontal themes/legislation Nanomaterial definition REACH Worker Protection Discussion on possible transparency measures Product specific legislation with explicit provisions on nanomaterials Cosmetics Food safety Biocides Other instruments with relevance for nanomaterials Electrical and electronic equipment, environmental legislation, (Waste, eco-label etc.), Medical products Plant protection products

Get to terms with the discrepancy between public discussion and economic reality of nanomaterials and nanotechnology Fair and proportionate treatment of nanomaterials in terms of safety regulation, taking into account existing knowledge on: hazards and risks of nanomaterials likelihood and seriousness of potential incidents. Nanomaterial legislation: Perspectives

Key instruments : Adapting REACH Annexes in a cost-efficient way, i.e.: requiring clarity of REACH dossiers and additional information where it is needed taking into account the cost of generating new information Finding the right instrument to increase transparency on nanomaterials on the market, which : Is cost-efficient in terms of developing key information at a low administrative burden to authorities and companies Can contribute to a better understanding and prioritisation of nanomaterial safety issues at regulatory and risk assessment level Is accessible and understandable for consumers and workers Nanomaterial legislation: Perspectives

If any, which nanomaterials are particularly toxic due to their particle size (as opposed to chemical identity)? – "Drivers of toxicity" Risk assessment of examples of nanomaterials – substance evaluation under REACH Is there indeed bioaccumulation in realistic exposure scenarios? – Epidemiological studies on workers Improving REACH-dossiers and Safety Data Sheets Better risk assessment for ultrafine particles in air Where else are information gaps?

Thank you for your attention!